Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head (EZAPCOFH)

This study has been completed.
Sponsor:
Collaborator:
Novartis Korea Ltd.
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00939900
First received: July 14, 2009
Last updated: March 15, 2013
Last verified: March 2013

July 14, 2009
March 15, 2013
July 2009
June 2012   (final data collection date for primary outcome measure)
We will evaluate percent of collapse of femoral head measured by X-ray and CT and/or MRI (pelvis AP, frog leg lateral, hip axial), and degree of dome depression over 24 months [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00939900 on ClinicalTrials.gov Archive Site
  • Collpase rate of femoral head [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ] [ Designated as safety issue: Yes ]
  • Change of HHS (Harris Hip Scores), WOMAC score, SF-36 [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ] [ Designated as safety issue: Yes ]
  • Time to collapse of femoral head [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ] [ Designated as safety issue: Yes ]
  • Time to total arthroplasty or joint preserving surgery [ Time Frame: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head
Multicenter, Open-labeled, Randomized Clinical Trial to Determine the Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head

The purpose of this study is to test the effect of zoledronic acid over 2 years in preventing early collapse and progression of joint dome depression (≥ 2 mm by X-ray) of the femoral head in patients with large (> 30%: criteria according to Kim et al) nontraumatic osteonecrosis.

Until now, the best treatment option in early (precollapse) large osteonecrosis femoral head is vascularizing fibular graft. However, it requires high microsurgical technique. Also it needs very long operation time (3-6hours), and morbidity associated with surgery is not low. In early stage osteonecrosis, osteoclasts are activated and resorb the necrotic portion of bone and osteoblasts are followed to lay down new bone. This process can weaken the bone function to support loading and can lead to collapse of bone. Bisphophonate can inhibit this osteoclastic bone resorption and enhance osteoblastic new bone formation. Recently, everyday oral intake of alendronate with vitamin D and calcium had a high success rate to prevent the collapse and decrease of hip joint pain in a short-term follow-up. However, the compliance or adherence to everyday oral intake is questionable. Moreover, the exact comparison based on MRI according to various classifications is not available currently. There is no report about the effect of zoledronic acid to prevent early collapse and progression of joint dome depression (≥2 mm by X-ray) of the early stage large nontraumatic osteonecrosis of the femoral head or its effect on MRI signal change after infusion of zoledronic acid in noncollapsed cases (estimated about 30% of cases) The investigators need a controlled randomized multicenter interventional study about the efficacy of bisphophonates in the treatment of ONFH.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Avascular Necrosis of Femoral Head
Drug: zoledronic acid (aclasta)
Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period
Other Name: aclasta
  • Experimental: aclasta
    aclasta group
    Intervention: Drug: zoledronic acid (aclasta)
  • No Intervention: control
    control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient who agree to clinical trial
  • Patient who are more than 18 years of age
  • Osteonecrosis of the femoral head
  • Steinberg stage I, II non traumatic osteonecrosis of femoral head
  • Necrotic area of > 30% (HJ Kim et al )
  • JIC (Japanese Investigation Committee): C1 or C2 lateral lesion (by X-ray or MRI)

Exclusion Criteria:

  • Patients who are pregnant (patients who are of child bearing potential who are not practicing a reliable contraceptive method (oral, subcutaneous, mechanical, or surgical contraception)
  • Patients who have contraindicated condition to zoledronic acid such as chronic renal failure (calculated creatinine clearance less than 35.0 ml/min), severe heart disease such as atrial fibrillation, sensitive to bisphosphonates and hypocalcemia (serum calcium less than 8 mg/dl or 2.0 mmol/L)
  • Patients who have collapsed lesion including subchonral fracture
  • Patients who have multiple lesion of osteonecrosis of femoral head
  • Patients who received other kinds of bisphophonates or anabolic agents before zoledronic acid use
  • Patients with any medical or psychiatric condition which, in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial per protocol
  • Patients who are considered potentially unreliable and patients who may not reliably attend study visits
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00939900
CZOL446HKR08T
Yes
Kyung-Hoi, Koo/professor, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Novartis Korea Ltd.
Principal Investigator: Kyung-Hoi Koo, professor Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP